BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16207471 · Received January 19, 2023

    Report

    Report Number
    3006630150-2023-00135
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    November 23, 2022
    Report Date
    January 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED A WEEK FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7111313.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FEELING A ZAPPING SENSATION IN THE LEFT RIB AREA DUE TO LEAD MIGRATION, WHICH WAS CONFIRMED VIA FLUOROSCOPY IMAGING. REPROGRAMMING WAS ATTEMPTED, HOWEVER, UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING WAS ADDED OR REMOVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155568 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7109723 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention